Lay Summary: I review the history of Oncotype and comment on the current status of this no longer controversial test.
The published literature for Oncotype primarily consists of validation studies to identify the optimal set of cancer-related genes.
Recentlypublished is the first prospective, randomized clinical trial of Oncotype Dx™ – in node negative pateitns only . The protocol, under the National Cancer Institute’s (NCI) Program for the Assessment of Clinical Cancer Tests, is being reviewed by the NCI Central Institutional Review Board. Named TAILORx (Trial Assigning Individualized Options for Treatment), this multi-institutional trial will focus on patients with ER-positive, node negative tumors. It concluded that Clinical-risk stratification provided prognostic information that, when added to the 21-gene recurrence score, could be used to identify premenopausal women who could benefit from more effective therapy.
The American Society of Clinical Oncology (ASCO) has included Oncotype DX™ into its 2007 updated clinical guidelines for the use of tumor markers in breast cancer. NCCN has decided to include Oncotype in its 2008 guidelinesand BCBS issued a supportive TEC assessment. NCCN sets the tumor size at 0.5cm.
There are many insurers who decided to cover but even where there is not specific policy to cover, with the NCCN decision, I consider the evidence to show that Oncotype testing is no longer investigational.
Joseph A. Sparano et al,Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer N Engl J Med 2019; 380:2395-2405
I. Baker J et al. Tumor gene expression predicts distant disease-free survival (DDFS) in breast cancer patients with 10 or more positive nodes: High throughput RT-PCR assay of paraffin-embedded tumor tissues. Proc Am Soc Clin Oncol 2003;22:850 (abstract 3415)
Paik S, Shak S, Tang G et al. Multi-gene RT-PCR assay for predicting recurrence in node negative breast cancer patients – National Surgical Adjuvant Breast and Bowel Project (NSABP) studies B-20 and B-14. San Antonio Breast Cancer Symposium. San Antonio, TX, December 2003.
Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. NEJM 2004;351(27):2817-26
2007 TEC Assessment: Gene expression profiling for managing breast cancer treatment. www.bcbs.com/tec/vol20/20_03.html
National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Breast Cancer. http://nccn.org/professionals/physician_gls/PDF/breast.pdf, BINV-6.
Eileen Rakovitch et al, A population-based validation study of the DCIS Score predicting recurrence risk in individuals treated by breast-conserving surgery alone. Breast Cancer Research and Treatment July 2015, Volume 152, Issue 2, pp 389-39